Taiwan FDA registration 005d00e78b55b6e35fe81e672e987d5c

"Vstrip" All-in-One H. pylori Antigen Test(Non-sterile)

TW: "飛確" 一體化簡易幽門桿菌抗原檢驗試劑(未滅菌)

Taiwan·Risk Class 1·MD·Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory·Registered Jan 22, 2019 – Jan 22, 2024Expired

Registration details

Analysis ID: 005d00e78b55b6e35fe81e672e987d5c
License Form: Ministry of Health Medical Device Manufacturing No. 007630

Company information

Manufacturer: Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: PANION & BF BIOTECH INC.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C0003 Helicobacter serological reagent
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Jan 22, 2019
Expiry Date: Jan 22, 2024

About this record

Access comprehensive regulatory information for "Vstrip" All-in-One H. pylori Antigen Test(Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 005d00e78b55b6e35fe81e672e987d5c and manufactured by Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory. The authorized representative in Taiwan is PANION & BF BIOTECH INC..

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